Cancer Institute A national cancer institute
designated cancer center
Cancer Clinical Trials Office

OnCore

As a requirement of our NCI Cancer Center designation, the Cancer Institute must track all cancer-related clinical research, which includes, but is not limited to, clinical trials (interventional studies). All prospective cancer-related research studies of any type (therapeutic and non-therapeutic, intervention and non-intervention) and the accrual to these studies must be tracked in OnCore.

Therapeutic studies Clinical trials with therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions.

Non-therapeutic studies include prevention, supportive care, screening, early detection, diagnostic, epidemiologic, observational, outcome, ancillary and correlative studies.

Intervention Studies (Clinical Trials) include therapeutic, intervention prevention and intervention supportive care studies. The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).

Non-Intervention Studies (Clinical Research Studies) include non-intervention prevention, non-intervention supportive care, epidemiologic, observational, correlative, early detection, screening, diagnostic, outcomes or ancillary studies.

OnCore®, Stanford’s secure centralized system for tracking cancer-related clinical research, is licensed from Forte Research Systems, Inc. The secure OnCore server is housed on the Stanford campus and is supported by the School of Medicine IRT Data Center group.

Protocol Registration in OnCore

  1. As soon as the IRB application is submitted, complete the entire Protocol Registration Form and email it to CCTO-Intake@stanford.edu. The Protocol Registration Form is used to create the protocol record in OnCore and the Stanford Clinical Trials database, and subsequently, ClinicalTrials.Gov.

    Studies must be in OnCore prior to SRC review. The CCTO will download all documents from eProtocol and attach them in OnCore.

  2. Once all appropriate approvals and contracts are in place, the protocol may be opened to accrual. OnCore will send a “Ready to Open Study” notice. Please respond to that email with the correct Open to Accrual (Enrollment) date.

Study Participant Registration and Ongoing Study Conduct

  1. Once your study is Open to Enrollment, register your study participants in OnCore. As required by the SRC, all study participants must be registered in OnCore within 5 business days of signing the consent.

  2. When the status of your study changes (accrual suspension, accrual closure or study termination) send email to CCTO-OnCore@stanford.edu indicating the status change, reason for the change and initiator of the change, along with the OnCore and/or eProtocol protocol numbers.

For more information on using OnCore, see the OnCore v12 Quick Reference, or contact the OnCore team.

Study Data Collection Option for Investigator Initiated Studies

OnCore can be used to collect study data for Investigator Initiated trials. Contact CCTO-OnCore@stanford.edu to request assistance with the development of electronic Case Report Forms (eCRFs) in OnCore. CCTO staff works closely with study staff to create eCRFs and train study staff on data entry into the OnCore database.

ONCORE TRAINING
Basic Training:
General overview of and introduction to OnCore functionality, review of OnCore data entry requirements for research studies and hands-on practice plus OnCore homepage setup for your favorite protocols, participants, reports, searches and more
Advanced Training:
1) Reporting with OnCore - Reports, Protocol Search and Subject Search
2) Use of OnCore for investigator-initiated studies (Stanford only or Multi-site)
3) Open Session- continuation of advanced topics or topic of your choosing.
Apr 14 Basic Training Alway M206 1:00-3:30PM
May 19 Basic Training Alway M206 2:00-4:00PM
» To register for OnCore Training, email CCTO-OnCore@stanford.edu. Please note that CITI/HIPAA training must be completed prior to OnCore access and training.
OnCore Resources

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